| CTRI Number |
CTRI/2020/09/027625 [Registered on: 07/09/2020] Trial Registered Prospectively |
| Last Modified On: |
05/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of laser and electerosurgery pulpotomy in 4 to 8 yr old children |
|
Scientific Title of Study
|
To compare the effectiveness of laser pulpotomy and electrosurgery pulpotomy in 4 to 8 yr old children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEEPTI ARORA |
| Designation |
PG Student |
| Affiliation |
FACULTY OF DENTAL SCIENCES SGT UNIVERSITY |
| Address |
Room no. 6
Depatment of pediatric dentistry
FACULTY OF DENTAL SCIENCES
SGT UNIVERSITY
CHANDUBUDHERA
BADLI BASAI ROAD
GURUGRAM (HARYANA)
Room no. 6
Depatment of pediatric dentistry
FACULTY OF DENTAL SCIENCES
SGT UNIVERSITY
CHANDUBUDHERA
BADLI BASAI ROAD
GURUGRAM (HARYANA)
Gurgaon
HARYANA
122001
India |
| Phone |
9311641784 |
| Fax |
|
| Email |
mongadeepti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Gupta |
| Designation |
Professor and HOD |
| Affiliation |
FACULTY OF DENTAL SCIENCES SGT UNIVERSITY |
| Address |
Room no. 6
Department of pediatric and preventive dentistry
Faculty of Dental Sciences
SGT University
GURUGRAM
Room no. 6
Department of pediatric and preventive dentistry
Faculty of Dental Sciences
SGT University
GURUGRAM
Gurgaon
HARYANA
122001
India |
| Phone |
9899039805 |
| Fax |
|
| Email |
anilgupta_in@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepti Arora |
| Designation |
PG Student |
| Affiliation |
FACULTY OF DENTAL SCIENCES SGT UNIVERSITY |
| Address |
Room no. 6
Department of pediatric and
Preventive dentistry
FACULTY OF DENTAL SCIENCES
SGT UNIVERSITY
CHANDUBUDHERA
BADLI BASAI ROAD
GURUGRAM (HARYANA)
Room no. 6
Department of pediatric and
Preventive dentistry
FACULTY OF DENTAL SCIENCES
SGT UNIVERSITY
CHANDUBUDHERA
BADLI BASAI ROAD
GURUGRAM (HARYANA)
Gurgaon
HARYANA
122001
India |
| Phone |
9311641784 |
| Fax |
|
| Email |
MONGADEEPTI@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| FACULTY OF DENTAL SCIENCES
SGT UNIVERSITY
CHANDUBUDHERA
BADLI BASAI ROAD
GURUGRAM (HARYANA) |
|
|
Primary Sponsor
|
| Name |
SGT DENTAL COLLEGE AND HOSPITAL |
| Address |
FACULTY OF DENTAL SCIENCES
SGT UNIVERSITY
CHANDUBUDHERA
BADLI BASAI ROAD
GURUGRAM (HARYANA) |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepti Arora |
SGT UNIVERSITY |
department of pediatric dentistry,room no. 6
Gurgaon
HARYANA |
9311641784
mongadeepti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMIITTEE |
Approved |
| university ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
oral cavity ,disease, dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diode laser pulpotomy |
pulpotomy of primary molar using diode laser as comparator over intervals of 3,6 and 12 months |
| Comparator Agent |
Electrosurgery pulpotomy |
pulpotomy of primary molars using electrosurgery as comparator agent over intervals of 3,6 and 12 months |
| Intervention |
pulpotomy |
pulpotomy of primary molars using laser and electrosurgery using clinical and radiographic examinations over intervals of 3,6 and 12 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
no swelling
no tenderness on percussion
no pathologic mobility
no sinus tract opening
no initially unsuccessful hemorrhage control |
|
| ExclusionCriteria |
| Details |
no spontaneous pain
primary molars with swelling or fistula
teeth which are nonrestorable
teeth with marked tenderness to percussion
teeth with excessive mobility
teeth with radiolucency in furcal or periapical area
teeth with pain especially at night
teeth with necrotic pulp
teeth near to exfoliation
parents /patient not willing to be part of study
any kind of medical history contraindicating pulp treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to maintain the integrity and health of decidous teeth by using laser and electrosurgery as pulpotomy agents |
3,6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effectiveness of Diode laser and electrosurgery as pulpotomy agents |
3,6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim is to maintain the integrity and health of decidous teeth by using Laser and Electrosurgery as pulpotomy agents.Objective is to evaluate the effectiveness of Diode Laser and Electrosurgery as pulpotomy agents.The sample size is 40 primary molars with follow up period of 3, 6 and 12 months.Results were evaluated with clinical and radiographic evaluation criteria. |